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NCT02454699 · ClinicalTrials.gov registry record · Phase 1
Safety and PK of MBX-400 (Cyclopropavir) in Normal Volunteers
A Phase 1 study of Cytomegalovirus Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT02454699: Completed Phase 1 study of Cytomegalovirus Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02454699 is a Phase 1 study of Cytomegalovirus Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 24 participants, below the 239-participant average among 5 other Cytomegalovirus Infection trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02454699, a Phase 1 study of Cytomegalovirus Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I safety, PK and food effect study of the CMV drug. In part 1 of the study, subjects will receive one of four dosage strengths of MBX-400 (100 mg once daily, 350 mg once daily; 750 mg once daily; and 1000 once daily) for 7 days and safety and PK will be assessed. Subjects must be 18 to 65 years of age, male or female; if female, be surgically-sterilized or post-menopausal; if male, have undergone vasectomy; have a body mass index (BMI) of 18 to 32 kg/m\^2; not be a user of nicotine-containing products; be willing to abstain from nicotine-containing products, alcohol and illicit drugs during the study. Subjects will be followed for 28 days post dosing.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG MBX400
Study Locations (1)
Georgia
- Emory Vaccine Center - The Hope Clinic - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-11-10 |
| Est. Completion | 2017-12-01 |
| Phase | Phase 1 |
What the finished NCT02454699 record still lists
NCT02454699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 239-participant average among 5 other Cytomegalovirus Infection trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Cytomegalovirus Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02454699 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT02454699 about?
NCT02454699 is a clinical study titled "Safety and PK of MBX-400 (Cyclopropavir) in Normal Volunteers". This is a phase I safety, PK and food effect study of the CMV drug. In part 1 of the study, subjects will receive one of four dosage strengths of MBX-400 (100 mg once daily, 350 mg once daily; 750 mg once daily; and 1000 once daily) for 7 days and safety and PK will be assessed. Subjects must be 18 ...
What is the current status of trial NCT02454699?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2015-11-10. Estimated completion is 2017-12-01.
What conditions does trial NCT02454699 study?
This clinical trial studies the following conditions: Cytomegalovirus Infection.
What interventions are being tested in trial NCT02454699?
The interventions under investigation include: Placebo (OTHER), MBX400 (DRUG).
Who is sponsoring clinical trial NCT02454699?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02454699 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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